Scientific Opinion on the substantiation of health claims related to
proanthocyanidins from cranberry (Vaccinium macrocarpon Aiton) fruit
and defence against bacterial pathogens in the lower urinary tract
(ID 1841, 2153, 2770, 3328), “powerful protectors of our gums” (ID 1365),
and “heart health” (ID 2499) pursuant to Article 13(1) of Regulation (EC)
No 1924/2006[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3
European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe:
Vaccinium macrocarpon Aiton
cranberry
gums
health claims
heart
proanthocyanidins
urinary tract
1. Charakterystyka żywności / składnika
The foods/food constituents that are the subject of the health claims are “Sqeez Cranberry Juice Drink”, “proanthocyanidins in cranberry juice”, “Vaccinium macrocarpon, oxycoccus (Common Name: Cranberry)”, “whole cranberry powder from North American Cranberry (Vaccinium macrocarpon) Early Black species”, and “cranberry extract powder (Vaccinium macrocarpon)”.
In the information provided, a number of food products derived from two varieties of cranberry (Vaccinium macrocarpon Aiton and Vaccinium oxycoccos L.) fruit were mentioned i.e. cranberry juice; diluted cranberry juice concentrate; cranberry juice cocktails; cranberry extracts, powders, and capsules. The Panel notes that the composition and/or manufacturing process for these cranberry-derived food products are not specified in the information provided. The Panel also notes that no human studies have been provided using cranberry fruit products derived from V. oxycoccos L.
The conditions of use related to some of these claims specify the amount of cranberry fruit products to be consumed in order to obtain the claimed effects in relation to their proanthocyanidin (PAC) content. The PAC fraction isolated from cranberries (V. macrocarpon Aiton) is a mixture of catechin and epicatechin oligomers of various molecular weights, and consists of predominantly procyanidin pentamers and tetramers containing at least one A-type linkage (Cunningham et al., 2002; Foo et al., 2000).
The Panel considers that whereas various food products derived from cranberry fruits, i.e. cranberry juice; diluted cranberry juice concentrate; cranberry juice cocktails; cranberry extracts, powders, and capsules, are not sufficiently characterised in relation to the claimed effects, PAC from cranberry (V. macrocarpon Aiton) fruit are sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Ochrona przed bakteriami patogennymi w dolnych drogach moczowych (ID 1841, 2153, 2770, 3328)
The claimed effects are “urinary tract”, “health of the lower urinary tract”, and “reduce biofilms on uroepithelial cells”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, clarifications from Member States and references provided, the Panel assumes that the claimed effects refer to defence against bacterial pathogens in the lower urinary tract, which can be assessed in vivo as changes in the incidence of symptomatic urinary tract infections (UTIs).
The Panel considers that defence against bacterial pathogens in the lower urinary tract is a beneficial physiological effect.
2.2. Mocna ochrona naszych dziąseł (ID 1365)
The claimed effect is “powerful protectors of our gums”. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined, and no further details were provided in the proposed wordings. No clarifications were provided by Member States.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
2.3. Zdrowie serca (ID 2499)
The claimed effect is “heart health”. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined, and no further details were provided in the proposed wordings or clarifications provided by Member States.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka -
3.1. Ochrona przed bakteriami patogennymi w dolnych drogach moczowych (ID 1841, 2153, 2770, 3328)
The references provided for the scientific substantiation of the claim included several narrative reviews and monographs which did not provide original data for the scientific substantiation of the claim, and some human intervention studies which investigated the effects of food constituents other than PAC in cranberry fruit products (e.g. cranberry products in combination with warfarin or flurbiprofen, and mixtures of concentrates from cranberries and lingonberries) or addressed health outcomes (e.g. risk of urolithiasis) other than the claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
A systematic review of randomised or quasi-randomised human intervention studies on the effects of cranberry and blueberry products on the incidence of symptomatic UTIs, 12 human intervention
studies and one observational study on the effects of cranberry fruit products on the incidence of UTI, and 17 non-human studies on the mechanisms by which cranberry fruit products could exert the claimed effect were provided.
A claim on cranberry (V. macrocarpon Aiton) fruit products standardised by their PAC content and reduction in the risk of UTIs in women by inhibiting the adhesion of certain bacteria in the urinary tract has already been assessed with an unfavourable outcome (EFSA, 2009). The scientific evaluation was based on the insufficient evidence provided by the applicant to establish a cause and effect relationship between the consumption of cranberry fruit products standardised by their PAC content and a reduction in the incidence of UTIs, and on the insufficient evidence provided to establish that the bacterial anti-adherence effects, which were shown in vitro, of cranberry fruit products in urine could predict the occurrence of a clinically relevant bacterial anti-adherence effect within the urinary tract in vivo in humans.
Most of the references provided in the consolidated list which addressed the effects of cranberry (V. macrocarpon Aiton) fruit products standardised by their PAC content on the incidence of UTIs in different population sub-groups, and those which addressed the mechanisms by which cranberry fruit products could exert the claimed effect, were already considered in the previous opinion (EFSA, 2009).
Two additional references, which reported on human intervention studies and which were not considered in the previous opinion, were provided in the consolidated list (Bohbot, 2007; Jepson and Craig, 2008). The Panel notes that the methods used to diagnose UTI infection were not sufficiently described in the study by Bohbot (2007). It is also noted that all human trials analysed in the Cochrane review by Jepson and Craig (2008) were referenced also in the systematic review by Jepson and Craig (2007) which was considered in the previous opinion (EFSA, 2009). The Panel considers that these two references do not provide any additional scientific data which could be used to substantiate the claim.
The Panel considers that the references provided for this claim did not provide any additional scientific data which could be used to substantiate the claim.
The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of proanthocyanidins from cranberry (V. macrocarpon Aiton) fruit and defence against bacterial pathogens in the lower urinary tract.
Wnioski
On the basis of the data presented, the Panel concludes that:
Whereas various food products derived from cranberry fruits, i.e. cranberry juice; diluted cranberry juice concentrate; cranberry juice cocktails; cranberry extracts, powders, and capsules, are not sufficiently characterised in relation to the claimed effects considered in this opinion, proanthocyanidins from cranberry (Vaccinium macrocarpon Aiton) fruit are sufficiently characterised.
Defence against bacterial pathogens in the lower urinary tract (ID 1841, 2153, 2770, 3328)
The claimed effects are “urinary tract”, “health of the lower urinary tract”, and “reduce biofilms on uroepithelial cells”. The target population is assumed to be the general population. In the context of the proposed wordings, clarifications from Member States and references provided, it is assumed that the claimed effect refers to defence against bacterial pathogens in the lower urinary tract. Defence against bacterial pathogens in the lower urinary tract is a beneficial physiological effect.
A claim on cranberry (Vaccinium macrocarpon Aiton) fruit products standardised by their proanthocyanidin content and reduction in the risk of urinary tract infections in women by inhibiting the adhesion of certain bacteria in the urinary tract has already been assessed with an unfavourable outcome. The references provided for this claim did not provide any additional scientific data which could be used to substantiate the claim.
The evidence provided is insufficient to establish a cause and effect relationship between the consumption of proanthocyanidins from cranberry (V. macrocarpon Aiton) fruit and defence against bacterial pathogens in the lower urinary tract.
“Powerful protectors of our gums” (ID 1365)
The claimed effect is “powerful protectors of our gums”. The target population is assumed to be the general population. The claimed effect is not sufficiently defined.
The claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
“Heart health” (ID 2499)
The claimed effect is “heart health”. The target population is assumed to be the general population. The claimed effect is not sufficiently defined.
The claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.